RecruitingNot ApplicableNCT06699875

Conventional Therapy vs. Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal

Comparative Study of the Effectiveness Between Models of Conventional Therapy vs Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal (Axillary Lymphadenectomy) as Part of Therapy Against Breast Cancer.


Sponsor

Trak Health Solutions S.L.

Enrollment

40 participants

Start Date

May 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the effectiveness of digital physiotherapy via Trak telerehabilitation with conventional home-based exercises in women who have undergone axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer treatment. Researchers will compare the Trak telerehabilitation platform to a standard home exercise protocol to assess the impact on shoulder mobility, treatment adherence, and overall patient satisfaction. Participants will undergo a 4-week home-based rehabilitation using Trak (treatment group) or follow a paper-based exercise protocol (control group) and attend follow-up visits to measure shoulder mobility and any necessary adjustments in treatment.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Female patients equal to or older than 18 years old.
  • Patient undergoing axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer therapy.
  • Patients with a tablet, smartphone, or laptop who can use electronic devices (or with family support).
  • Patient with an e-mail account (or willing to generate a new one).
  • Signed the informed consent.

Exclusion Criteria4

  • Patient with cognitive restriction
  • Patient receiving adjuvant chemotherapy (after lymphadenectomy)
  • Patient with previous shoulder-limiting pathology (cuff tear, chronic pain, shoulder fracture with sequelae of limited mobility)
  • Patient who has undergone previous surgery on the same shoulder.

Interventions

OTHERTrak exercise prescription protocol at home

Online exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises.

OTHERConventional rehabilitation plan at home

Treatment is based on therapeutic exercise following a conventional rehabilitation plan on paper. The patient will undergo 4 weeks of an exercise prescription protocol based on mobility exercises.


Locations(1)

Donostia University Hospital (HU Donostia, OSI Donostialdea)

Donostia / San Sebastian, Basque Country, Spain

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NCT06699875


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